Methods and devices for aseptic irrigation, urine sampling, and flow control of urine from a catheterized bladder

Abstract

A connector system includes a catheter connector port to attach to a urinary catheter, a urine exit port to connect to a urine collection device, an irrigation port to receive an irrigation syringe, and an internal valve. The irrigation port includes a pliable membrane that has a self-sealing opening to allow a tip of the syringe to extend therethrough. The internal valve cooperates with the syringe to shut off flow of fluid to the urine exit port when the syringe is inserted and allow for flow of fluid to the urine exit port when the syringe is removed. A distance between a proximal surface of the membrane and a distal end of the internal valve is such that the tip of the syringe can extend from a proximal end of the self-sealing opening to the distal end of the internal valve.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. patent application Ser. No. 13 / 414,205, titled “METHODS AND DEVICES FOR ASEPTIC IRRIGATION, URINE SAMPLING, AND FLOW CONTROL OF URINE FROM A CATHETERIZED BLADDER,” filed Mar. 7, 2012, now U.S. Pat. No. 9,060,752, which claims the benefit under 35 U.S.C. § 119 of U.S. Provisional Patent Application No. 61 / 464,705, titled “‘SELF-CLOSING PORT AND VALVE ASSEMBLY’ AN APPARATUS FOR IMPROVED IRRIGATION AND DRAINAGE OF THE CATHETERIZED BLADDER,” filed Mar. 8, 2011, the disclosure of which is incorporated herein by reference.INCORPORATION BY REFERENCE[0002]All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD[0003]This invention relates to methods, systems, and apparatuses to assist with ...

AI Technical Summary

Benefits of technology

The present invention is a system, method, and apparatus for improved aseptic irrigation, urine sampling, and flow control of urine from a catheterized bladder. The system includes a port and valve assembly that allows for aseptic irrigation and urine sampling without disconnecting the catheter from the drainage bag. The system also includes an internal valve that can shut off the flow of fluid and air from the urine collection device, allowing for bladder training and increased safety and convenience. The system can decrease the chance of urinary tract infection, bladder atony, and blood and body fluid exposure, and greatly simplify the procedure of bladder irrigation of the catheterized patient.

Problems solved by technology

Existing urinary catheter technology results in numerous health and safety issues for patients, medical personnel, and the community at large.

In addition to direct patient complications, there are numerous safety issues related to current urinary catheter systems, both in the inpatient setting and in the home health setting.

Present systems put clinicians at risk of occupational injury related to bio-hazardous waste exposure.

Because the current available catheter technology demands that the catheter be disconnected from the urine collection device in order to irrigate the system, leaking or spilling of urine often occurs during these procedures.

When these spills and splashes occur, clinicians, other patients, and the community at large are put at risk for cross contamination and the spread of infection, including antibiotic resistant pathogens.

In summary, most of the problems listed above arise, at least in part, from two primary problems with existing catheter systems: (1) Current catheter systems do not allow for the maintenance of a closed, aseptic system; and (2) Current catheter systems do not allow the bladder to fill and empty in a normal fashion.

They found both older and more recent data indicating that disconnection of the urine collection device from the catheter is a risk factor for bacteriuria.

However, the device of Russo does not provide for an aseptic irrigation procedure.

The plastic entrance port disclosed by Russo does not have a flat, easily sanitizable surface, but has a crevice that cannot be effectively sanitized.

Bacteria hiding on this un-sanitizable surface can enter the system during irrigation and infect the patient.

The second major problem with current catheter systems is that they drain the bladder constantly, not allowing it to fill and empty in a normal manner.

Catheter blockage is another problem with “constant drain” catheter systems and is caused by the buildup of biofilm and salt crystals at the opening of the catheter.

With CAUTI, the bladder wall becomes irritated and even swells, causing spasms.

The loss of normal stretching and contracting of the detrusor can also cause spasms.

Catheter-related bladder atony is another complication associated with not allowing the bladder to fill and empty.

When the bladder no longer fills and empties in a normal fashion, the detrusor muscle can atrophy, causing a temporary or even permanent inability to void after catheterization.

None of the prior art in this area discloses sanitizable surfaces on entry ports leading from the outside to the inside of the closed urinary drainage system.

These prior art systems thus often complicate the problem by introducing bacteria into what should be a closed system.

It is not adequate to simply swab an exposed unprotected end of a urine collection device that was disconnected from the system with a disinfectant prior to reconnection to the catheter end.

However, these reusable covers are generally not adequate and tend to lead to contamination of the system.

This is because the covers can be contaminated in between uses and are not sanitizable on the inside surface that comes into contact with the connecting end.

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